Clinical trials have improved the treatment of cancer, and it has been shown that participants in cancer clinical trials have better outcomes than does the population at large.1 However, a number of barriers to participation in clinical studies exist, especially in minority populations. Indeed, it has been estimated that <5% of US cancer patients are enrolled in oncology clinical trials, and ethnic minorities and individuals of low socioeconomic status are even less likely to be trial participants.2
The recruitment and retention of racial/ethnic minority participants in clinical trials continue to be a major challenge across a wide variety of healthcare settings, including cancer trials (Figure).3 Recent studies have shown that minority candidates for clinical trials are significantly less likely than whites to be approached about study participation and to be enrolled in oncology clinical studies and in studies evaluating new molecular-entity drugs and biological products.4,5 Although few studies have been conducted on racial/ethnic differences in participant retention in clinical trials, the evidence shows that retention rates in trials are also significantly lower for minorities and those who speak a language other than English at home.6-8
Barriers that exist to minority participation in clinical trials can occur at the patient, provider, and/or system levels.9
- Provider-level barriers include a general lack of time to enroll patients in clinical trials and a bias that minority patients will not be interested or compliant
- Patient-level barriers include minority patients' distrust of the medical system, uneasiness with the concept of randomization, and concern regarding extra costs associated with participating in a clinical trial
- System-level barriers include lack of accessibility to a clinic with clinical trials and availability of applicable clinical trials for minority patients
Considerable attention has been focused on the need to increase underserved racial and ethnic populations in clinical research, especially in light of the cancer health disparities that disproportionately affect these groups.10-12 But what methods or practices work best to improve the representation of racial and ethnic minorities in cancer clinical trials?
NRG Oncology is a nonprofit research organization formed to conduct oncologic clinical research and to broadly disseminate study results for informing clinical decision-making and healthcare policy. It brings together the National Surgical Adjuvant Breast and Bowel Project, the Radiation Therapy Oncology Group, and the Gynecologic Oncology Group—each recognized internationally as a research leader.13 A recent study by the NRG Oncology group probed 556 NRG Network Lead Research Associates and Local Site Research Associates on recruitment strategies that have worked for minority/underserved participants.9 The methods that worked best for recruiting minority/underserved trial participants are presented in the Table:
- More than 44% of the respondents indicated that the use of patient navigators was one of the most effective methods of improving recruitment of minority/underserved participants into cancer clinical trials, particularly in assisting with clinical trial education
- Communication about clinical trial opportunities through postings on institutional websites and through written materials translated into languages other than English were also reported to be effective
- The use of financial incentives was reported to be effective in recruiting minority/underserved participants for overall recruitment, including the use of travel reimbursements and monetary incentives
Other studies have also reported the value of nurse and patient navigators in the recruitment and retention of minority cancer patients onto oncology clinical trials, particularly as it relates to patient education about clinical studies and providing navigation support. For example, Project IMPACT showed that when patient navigation services were provided, 80% of eligible African American patients with cancer enrolled in a clinical trial, and 75% completed the trial, compared with 38% of those not receiving navigation support (P <.001).14 This was accomplished primarily by identifying and addressing potential barriers to compliance with treatment protocols.
Time and again, oncology nurses and nurse and patient navigators highlight the importance of creating a sense of connection with potential participants as part of the recruitment and retention process of minorities in cancer clinical trials. Building a relationship, however fleeting, may include a number of concrete behaviors, including listening to personal information, expressing empathy, and providing reciprocal self-disclosures; having repeated contact, usually by working in the same environment over an extended period; demonstrating respect through politeness and the use of honorifics; going the extra mile for participants; offering flexibility in scheduling follow-up appointments; and creating a sense of personal and community trust by being truthful. You need to be a good listener and use relational communication behaviors to enhance minority recruitment into oncology clinical studies.
Past abuses of human rights in the conduct of clinical research have left a legacy of mistrust regarding the healthcare delivery system, and it has been documented among potential clinical trial participants in both cancer and noncancer clinical trials, but it is particularly pronounced among racial/ethnic minorities.15 Improving successful accrual diversity requires education and behavior modification at both the provider and patient levels. Patients should be educated regarding the safety and advantages of clinical trial participation. Providers must be educated regarding the critical importance of diversity in the implementation of a meaningful clinical trial, and to resist the temptation to assume that a patient will not be interested in a clinical trial because of their ethnic background and/or socioeconomic status. Thus, a balanced presentation of all treatment options, including clinical trial participation, is critical, and mandatory cultural competency training for research staff is important in effectively recruiting and retaining minority patients in cancer clinical trials.9
Although clinical trials have improved the treatment of cancer, a number of barriers to participation in clinical studies exist, especially in minority populations and individuals of low socioeconomic status. Minority involvement in oncology clinical trials is essential to promote diversification in cancer research. Nurse and/or patient navigators are uniquely qualified to advocate for, and ensure the success of, minority participants in oncology clinical trials through a process of education, personalized communication to enhance recruitment, realistic informed consent, and support throughout the clinical trial process. The commitment of the nurse/patient navigators is paramount in that they must be culturally sensitive and aware of the impact of appropriate communication and patient trust.
- Symonds RP, Lord K, Mitchell AJ, Raghavan D. Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. Br J Cancer. 2012;107:1017-1021.
- Ford JG, Howerton MW, Lai GY, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008;112:228-242.
- Brooks SE, Muller CY, Robinson W, et al. Increasing minority enrollment onto clinical trials: practical strategies and challenges emerge from the NRG Oncology accrual workshop. J Oncol Pract. 2015;11:486-490.
- Scalici J, Finan MA, Black J, et al. Minority participation in Gynecologic Oncology Group (GOG) studies. Gynecol Oncol. 2015;138:441-444.
- Eshera N, Itana H, Zhang L, et al. Demographics of clinical trials participants in pivotal clinical trials for new molecular entity drugs and biologics approved by FDA from 2010 to 2012. Am J Ther. 2015;22:435-455.
- Dhalla S, Poole G. Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention. Hum Vaccin Immunother. 2014;10:1974-1984.
- Baxter J, Vehik K, Johnson SB, et al. TEDDY Study Group. Differences in recruitment and early retention among ethnic minority participants in a large pediatric cohort: the TEDDY Study. Contemp Clin Trials. 2012;33:633-640.
- Osann K, Wenzel L, Dogan A, et al. Recruitment and retention results for a population-based cervical cancer biobehavioral clinical trial. Gynecol Oncol. 2011;121:558-564.
- Cook ED, Yeager KA, Cecchini RS, et al. Recruitment practices for U.S. minority and underserved populations in NRG oncology: results of an online survey. Contemp Clin Trials Commun. 2018;10:100-104.
- Denicoff AM, McCaskill-Stevens W, Grubbs SS, et al. The National Cancer Institute-American Society of Clinical Oncology Trial Accrual Symposium: summary and recommendations. J Oncol Pract. 2013;9:267-276.
- McCaskill-Stevens W, Wilson JW, Cook ED, et al. National Surgical Adjuvant Breast and Bowel Project study of tamoxifen and raloxifene trial: advancing the science of recruitment and breast cancer risk assessment in minority communities. Clin Trials. 2013;10:280-291.
- Wallington SF, Luta G, Noone AM, et al. Assessing the awareness of and willingness to participate in cancer clinical trials among immigrant Latinos. J Community Health. 2012;37:335-343.
- NRG Oncology. www.nrgoncology.org. Accessed August 10, 2018.
- Fouad MN, Acemgil A, Bae S, et al. Patient navigation as a model to increase participation of African Americans in cancer clinical trials. J Oncol Pract. 2016;12:556-563.
- Diehl KM, Green EM, Weinberg A, et al. Features associated with successful recruitment of diverse patients onto cancer clinical trials: report from the American College of Surgeons Oncology Group. Ann Surg Oncol. 2011;18:3544-3550.